EU Investigates Concerns Around Cervical Cancer Vaccine

A review of the HPV vaccine for cervical cancer is to take place in Europe arising from concerns about possible side effects among young women, Mairead McGuinness, Fine Gael MEP and Vice-President of the European Parliament has said today (Monday) following confirmation she received from EU Health Commissioner Andriukaitis.

The MEP, who is leading Europe’s review of medical devices for the EPP, the largest political grouping in the European Parliament, took action following reports in Ireland of young girls experiencing a range of symptoms following administration of the vaccine. She said similar reports have emerged from other member states, in particular Denmark.

“The review being carried out by the European Medicines Agency, will look at available data with a focus on rare reports of two conditions, complex regional pain syndrome and postural orthostatic tachycardia syndrome associated with heart rate increase,” the MEP said.

The EU Commission had granted marketing authorisation to four human HPV (papillomavirus) vaccines – Cervarix, Gardasil, Silgard and Gardasil 9 and the authorisation process involves the provision of relevant information about safe use and potential side effects of these products. Such information is available in a public Community Register of medicinal products, as are suspected adverse drug reactions related to HPV vaccines in what is called the Eudravigilance database.

Ms McGuinness said after an authorisation all medicines in the EU are subject to a post-marketing surveillance and the obligations in this period on marketing authorisation holders and competent authorities are set out in legislation.

“These obligations were strengthened with the revision of the pharmaceutical legislation in 2010,” she said.

An Irish support group REGRET has been set up by parents with concerns about the health of their children post vaccination.